| Product Information |
|
| Registration Number |
DRP-13481
|
| Generic Name |
Bupivacaine (as hydrochloride) w/ Dextrose
|
| Brand Name |
Bupivasaph-D
|
| Dosage Strength |
5 mg/mL
|
| Dosage Form |
Solution for Injection (Intrathecal)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Local Anesthetic
|
| Packaging |
USP Type I Flint Ampoule x 4 mL (Box of 10 ampoules in plastic tray)
|
| Manufacturer |
Kilitch Drugs (India) Ltd.
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial (Correction)
|
| Issuance Date |
18 June 2024
|
| Expiry Date |
23 February 2028
|